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Optimization of clean-in-place parameters and comparative analysis of surface cleanability in pharmaceutical and cosmetic manufacturing

Budak Yakup

Scientiae Radices

2025

Vol. 4, Iss. 2

115--131

This study focused on cleaning validation (CV), emphasizing the importance of preventing cross-contamination and ensuring product safety in the pharmaceutical and cosmetic industries. The cleanability of detergent, metal, and active pharmaceutical ingredient (API) residues was evaluated on various surfaces, including stainless steel (316 L), borosilicate glass, and polymers such as polyethylene (PE) and polypropylene (PP). The effectiveness of clean-in-place (CIP) treatments using alkaline (CIP-100) and acidic (CIP-200) detergents was evaluated in combination with APIs such as amlodipine and nabumetone. Surfaces were contaminated and subjected to CIP protocols at 25°C and 60°C, with rinse water volumes ranging from 50 to 250 mL. pH analysis, conductivity measurements, and high-performance liquid chromatography quantified residual contaminants. The results showed that the CIP treatment effectively reduced metal residues below safety thresholds, with API recovery rates between 91.2% and 97.5%. Although polymer surfaces showed chemical inertness with less metal ion release, they exhibited lower efficiency in cleanability due to their hydrophobic nature and surface roughness (Ra: 0.8-1.2 μm). Higher CIP temperatures increased cleaning efficiency, while lower rinse water volumes decreased efficiency. The study optimized CIP parameters, highlighting the advantages of polymer materials in minimizing contamination and balancing rinse water usage and cleaning efficiency.

Development and validation of a high-performance liquid chromatographic method for analysis of nimesulide residues on manufacturing equipment surfaces

Milenović D. M., Todorović Z. B.

Acta Chromatographica

2009

Vol. 21, no. 4

603--618

In the pharmaceutical industry it is important to remove drug residues from the equipment and areas used. Cleaning procedures must be validated, so special attention must be devoted to the methods used for analysis of trace amounts of drugs. To monitor a cleaning procedure, a high-performance liquid chromatographic method for analysis of nimesulide residues in swab samples has been developed and validated. The swabbing procedure was optimized to achieve suitable recovery of nimesulide from stainless steel. Mean recovery was >80% when two swabs were used. The precision of the results, reported as the relative standard deviation (RSD), was <2.00%. The method was validated over the concentration range 0.30–50.00 μg mL -1. Small amounts of the drug residues were analysed by HPLC with an ODS column (250 mm × 4.6 mm, 5-μm particles), at 20°C, with 65:35:3:0.13 ( v/v/v/w ) methanol-water-phosphate buffer (pH 3; 0.05 M )-sodium heptane sulfonate as mobile phase at a flow rate of 0.8 mL min -1. Nimesulide was detected at 235 nm. This procedure enabled simple, sensitive, and convenient HPLC analysis of nimesulide residues on stainless steel.